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Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
Date:4/27/2011

at least 15 letters of vision from baseline, compared to 22.1 percent of patients receiving sham injections (p<0.0001), the primary endpoint of the study.  Patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001), a secondary endpoint.

VEGF Trap-Eye was generally well tolerated and the most common adverse events were those typically associated with intravitreal injections or the underlying disease.  Serious ocular adverse events in the VEGF Trap-Eye group were 2.9 percent and were more frequent in the control group (8.8 percent).  The most frequently reported adverse events overall in the VEGF Trap-Eye arm were eye pain, conjunctival hemorrhage and elevated intraocular pressure.  The most frequently reported adverse events in the control group were macular edema, eye irritation, and reduction of visual acuity.  The incidence of non-ocular serious adverse events was generally well-balanced between the treatment arms.  The most frequent non-ocular adverse events were headache and nasopharyngitis.  There were no deaths in the study.

About Central Retinal Vein Occlusion (CRVO)

Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from CRVO.  CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina.  This causes retinal injury and loss of vision.  The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications.  Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and inappropriate new vessel growth.  It is believed that anti-VEGF treatment may help decrease vascular permeab
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SOURCE Regeneron Pharmaceuticals, Inc.
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